The following data is part of a premarket notification filed by Newdeal Sas with the FDA for Newdeal Compression Plate.
| Device ID | K091609 |
| 510k Number | K091609 |
| Device Name: | NEWDEAL COMPRESSION PLATE |
| Classification | Plate, Fixation, Bone |
| Applicant | NEWDEAL SAS 311 ENTERPRISE DR. Plainsboro, NJ 08536 |
| Contact | Judith E O'grady |
| Correspondent | Judith E O'grady NEWDEAL SAS 311 ENTERPRISE DR. Plainsboro, NJ 08536 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-03 |
| Decision Date | 2009-06-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780044345 | K091609 | 000 |
| 10381780044338 | K091609 | 000 |
| 00885556910252 | K091609 | 000 |
| 00885556910276 | K091609 | 000 |
| 00885556910269 | K091609 | 000 |